Identity
- Trade Name
- Discovery 670 ES FDA UDI
- Generic Name
- Stationary gamma camera system FDA UDI
- Model / Reference
- H3100AG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682121187 FDA UDI
- 510(k) Number
- K093514 FDA UDI
- FDA Product Code
- KPS FDA UDIJAK FDA UDI
- GMDN Term
- Stationary gamma camera system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1200 FDA UDI892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Full-body CT systemStationary gamma camera system
Discovery 670 ES by Ge Medical Systems Israel , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K093514 also covers:
- D630 to D670 DR Upgrade — GE Hualun Medical Systems Co., Ltd
- 830 to 870 DR Upgrade — Ge Medical Systems Israel , Ltd.
- 830 to 870 DR Upgrade — Ge Medical Systems Israel , Ltd.
- 870ES to 870 DR Upgrade — Ge Medical Systems Israel , Ltd.
- D630 to D670 DR Upgrade — Ge Medical Systems Israel , Ltd.
- D670 Pro Upgrade — Ge Medical Systems Israel , Ltd.
- D670 Upgrade — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
- Discovery — Ge Medical Systems Israel , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ge Medical Systems Israel , Ltd.
Sources (1)
- FDA UDI 87874fe3-395e-413e-becc-43e256b4ad54 33 fields · synced May 31, 2026